The US Environmental Protection Agency (EPA) has proposed a ban on nearly all uses of dichloromethane, also known as dichloromethane, a commonly used solvent and processing aid. The proposed ban will have a significant impact on many industries, with between 100 and 250 million pounds of chemicals produced or imported in 2019. The few remaining uses, including use as a reagent for the production of HFC-32, will be subject to more stringent restrictions than current OSHA standards.
The EPA announced the proposed bans and restrictions in a proposed rule posted May 3, 2023, 83 Fed. register. 28284. This proposal would ban all other consumer uses of dichloromethane. Any industrial and commercial use of dichloromethane, including as a heat transfer fluid or other process aid, and most uses as a solvent, will also be prohibited, with the exception of ten specific uses, two of which are very specialized. Prohibited and excluded uses are listed at the end of this warning. Significant new usage rules in the future may cover uses not included in any of the lists.
The ten uses not covered by the ban will trigger a requirement to implement a Workplace Chemical Protection Plan (WCPP) based on the OSHA standard for methylene chloride, but with existing chemical exposure limits that are 92% lower than OSHA allows.
Interested parties have until July 3, 2023 to submit comments on the proposed rule. The EPA asked for comments on 44 topics, including whether the WCPP requirement should replace the specific use ban and whether an accelerated ban schedule is possible. The EPA has also requested comment on whether any prohibited uses qualify as critical or essential uses, as there are no safer alternatives available.
This proposal is the second proposed by EPA for ten key chemicals that are subject to risk assessment under Section 6 of the Toxic Substances Control Act (TSCA). First, this is a proposal to ban all other uses of chrysotile. The third rule concerns perchlorethylene, which has been under review by the Office of Management and Budget (OMB) since February 23, 2023. As of March 20, 2023, a draft final rule for chrysotile (see our warning) is under OMB review.
A June 2020 risk assessment found unwarranted risks in all but six conditions where methylene chloride was used. All six now appear in the list of proposed terms of use subject to WCPP requirements. The November 2022 revised definition of risk has shown that dichloromethane generally poses an unreasonable risk, with only one condition of use (commercial distribution) not affecting the definition. The proposed ban would include commercial distribution for prohibited uses, but not for WCPP-compliant uses. Having found that dichloromethane poses an unreasonable risk, Section 6(a) of the TSCA now requires the EPA to adopt risk management rules for the chemical to the extent necessary so that it no longer poses such a risk.
The EPA previously prohibited consumers from using methylene chloride to remove paint and coatings, 40 CFR § 751.105. The EPA is currently proposing to ban all consumer uses not covered by section 751.105, including the manufacture, processing, and commercial distribution of methylene chloride and products containing methylene chloride for these purposes.
In addition, the EPA is proposing to ban all industrial and commercial uses of dichloromethane that are not subject to WCPP requirements, including manufacturing, processing, commercial distribution, and use under these conditions of use.
The end of this warning lists 45 industrial, commercial, and consumer conditions that are proposed to be banned. This list is taken from the 2020 Risk Assessment. In addition, the EPA plans to adopt a Significant New Use Regulation (SNUR) that will apply to any dichloromethane or products containing dichloromethane not included in the risk assessment. The regulatory agenda published in January projects a proposed SNUR by April 2023 (EPA has already missed that date) and a final SNUR by March 2024.
The EPA estimates that this ban will account for about one-third of total annual methylene chloride production or imports for TSCA and other uses.
[T]he proposed rule will not apply to any substance excluded from the definition of “chemical” under Section 3(2)(B)(ii)-(vi) of the TSCA. These exclusions include, but are not limited to… any food, dietary supplement, drug, cosmetic, or device, as defined in Section 201 of the Federal Food, Drug, and Cosmetic Act, when manufactured, processed, or distributed for commercial purposes. . for use in foods, dietary supplements, drugs, cosmetics or equipment…
With regard to adhesives in the manufacture of batteries intended for medical use, as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act, those specified uses that qualify as “devices” if “manufactured, processed, or distributed for use as a device” would be removed from the definition of “chemical” and thus would not be subject to the regulation if it were further developed.
The use of dichloromethane as a functional liquid in a closed system in a pharmaceutical process requires its use as an extraction solvent in drug purification, and [EPA] has concluded that this use falls under the exceptions to the definitions above, and not “chemical” according to TSCA.
Prohibition of incentives that restrict the storage of methylene chloride and products containing methylene chloride. The EPA asks for comment on whether additional time is required, for example, to clean up distribution channels for banned products. Given the request for comment now, the EPA may be less inclined to consider extension requests at a later date.
As shown by the 45 Prohibited Use Conditions, methylene chloride is used in many industries, including as a solvent and as a processing aid. As a result, the proposal, if it is finalized, will affect dozens of industries. The 2020 Risk Assessment highlights some areas of application:
Dichloromethane has a wide range of uses, including sealants, automotive products, and paint and coating removers. Dichloromethane is well known as a process solvent in paint thinners and in pharmaceutical and film coating applications. It is used as a blowing agent for polyurethane and in the manufacture of hydrofluorocarbon (HFC) refrigerants such as HFC-32. It is also found in aerosol propellants and solvents used in electronics manufacturing, metal cleaning and degreasing, and furniture finishing.
The prospect of banning most uses of methylene chloride raises pressing questions about viable alternatives. EPA considers this issue when evaluating alternatives, which are described in the preamble as follows:
To determine the terms of use for products that currently contain methylene chloride, the EPA has identified hundreds of commercially available non-methylene chloride alternatives and, to the extent practicable, has listed their unique chemical composition or ingredients in the Alternatives Assessment. .
The EPA has identified 65 alternative products in the paint and coating remover category, of which furniture finishing is a subcategory (ref. 48). As noted in the economic analysis, while not all of these alternative products may be suitable for the specific purposes of some furniture repair applications, mechanical or thermal methods may be non-chemical alternatives to using products containing methylene chloride for paint and coating removal. … …The EPA believes there are technically and economically viable alternatives on the market…
[A] Alternatives to methylene chloride not identified as processing aids. The EPA is requesting information on potential alternatives to methylene chloride processing aids as it relates to proposed control options under this Agreement.
The lack of identified alternatives that can be used as adjuncts is a potential problem. The EPA describes the terms of use as:
The industrial or commercial use of dichloromethane to improve the performance of a process or process equipment, or when dichloromethane is added to a process or to a substance or mixture to be treated to change or buffer the pH of the substance or mixture. The treating agent does not become part of the reaction product and does not affect the function of the resulting substance or article.
Dichloromethane is used as a “process additive” and is used as a heat transfer medium in closed systems. The proposed rule would also ban this use of dichloromethane despite its low potential for exposure. However, the preamble adds:
The EPA has requested comments on the extent to which other organizations using methylene chloride as a processing aid will comply with the proposed WCPP requirement for methylene chloride. If several organizations can demonstrate through a combination of monitoring data and process descriptions that the continued use of methylene chloride does not expose workers to undue risk, the EPA confirms its willingness to finalize a regulation under which conditions [e.g. use as a heat transfer medium] or general conditions of use [as a processing aid] may continue in accordance with WCPP…
Thus, companies that use methylene chloride in applications with low impact potential, such as heat transfer fluids, have the option of asking the EPA to change a proposed ban on such use to require WCPP implementation—provided they can demonstrate to the EPA that they can comply with the WCCP requirements discussed below. The Environmental Protection Agency also stated:
If the EPA is unable to identify any alternatives to this condition of use and does not provide additional information to enable the EPA to determine that WCPP eliminates an unreasonable risk Appropriate Disposition.
Section 6(d) requires the EPA to require compliance as soon as possible, but no later than 5 years after the issuance of the final rule. In other words, such use may qualify for an extension of the compliance period.
For the ten conditions of use listed below, including production and processing to produce HFC-32, recycling and disposal, the EPA has proposed Workplace Exposure Controls (i.e. WCPP) as an alternative to the ban. Control measures include requirements for exposure limits, controlled areas, exposure monitoring (including new monitoring requirements in accordance with good laboratory practice), compliance practices, respiratory protection, skin protection, and education. These regulations supplement the OSHA methylene chloride standard 29 CFR § 1910.1052, but are largely based on that standard with one important change.
OSHA standards (originally adopted in 1997) have a Permissible Exposure Limit (PEL) of 25 ppm (8-hour time-weighted average (TWA)) and a Short Term Exposure Limit (STEL) of 125 ppm (15-minute TWA) . In comparison, the current TSCA Chemical Exposure Limit (ECEL) is 2 ppm (8 hour TWA) and the STEL is 16 ppm (15 minute TWA). So ECEL is only 8% of OSHA PEL and EPA STEL will be 12.8% of OSHA STEL. Control levels should be used in accordance with ECEL and STEL, with technical controls being the first priority and the use of personal protective equipment the last resort.
This means that individuals who meet OSHA requirements may not meet the recommended ECEL and STEL. Doubt about the ability to meet these exposure limits is a factor that has led the EPA to ban most industrial and commercial uses of methylene chloride and products containing methylene chloride.
In addition to the manufacturing and processing uses listed, WCPP provisions also apply to the disposal and processing of methylene chloride and products containing methylene chloride. As a result, waste disposal companies and recyclers who may not be familiar with TSCA requirements will need to move beyond OSHA standards.
Given the breadth of the proposed ban and the number of user industries that could be affected, comments on this proposed rule may be more important than usual. Comments will be submitted to EPA by July 3, 2023. The Preamble recommends that organizations submit comments on the paperwork requirements directly to the OMB by June 2, 2023.
Before commenting, companies and trade associations (from the perspective of their members) may wish to consider the following:
Commentators may want to detail their use of methylene chloride, their engineering controls to limit exposure, the current OSHA methylene chloride compliance program, the results of industrial hygiene monitoring of methylene chloride (and how it compares to the ECEL vs. STEL comparison). ; technical problems associated with identifying or switching to an alternative to methylene chloride for their use; the date by which they can switch to an alternative (if possible); and the importance of their use of methylene chloride.
Such comments could support an extension of the compliance period for its use, or an EPA requirement to exempt certain uses of methylene chloride from the ban under Section 6(g) of the TSCA. Section 6(g)(1) states:
If the administrator finds that…
(A) the specified uses are critical or essential uses for which there are no technically and economically feasible safer alternatives, taking into account the hazards and impacts;
(B) compliance with a requirement applicable to specific conditions of use is likely to seriously disrupt the national economy, national security, or critical infrastructure; or
(C) The specified conditions of use of the chemical or mixture provide a significant health, environmental or public safety benefit when compared to reasonably available alternatives.
Include conditions, including reasonable record keeping, monitoring and reporting requirements, to the extent that the Administrator determines that these conditions are necessary to protect health and the environment while meeting the purpose of the exemption.
The preamble states that the EPA will consider waiving Section 6(g) if there are no viable alternatives and meeting the WCPP requirements is not feasible:
Alternatively, if the EPA is unable to determine an alternative for this condition of use [as a heat transfer medium] and, based on new information, the EPA determines that a ban on use would seriously affect national security or critical infrastructure, the Agency The EPA will review the TSCA Section 6(g) exemption.
Commentators can indicate if they can meet the WCPP requirements, and if not, what limiting exposure requirements they can meet.
Disclaimer: Due to the general nature of this update, the information provided here may not apply in all situations, and should not be acted upon without specific legal advice based on your particular situation.
© Beveridge & Diamond PC var today = new Date(); var yyyy = today.getFullYear();document.write(yyyy + ” “); |律师广告
Copyright © var today = new Date(); var yyyy = today.getFullYear();document.write(yyyy + ” “); JD Ditto LLC